Neuroinflammatory DiseasesFIT-ATOMICNCT06870968
FIT-ATOMIC Exercise Feasibility Trial
A study testing Exercise Training and Mobility and Flexibility Training in people with Neuroinflammatory Diseases and Multiple Sclerosis, run by The Hospital for Sick Children at 4 sites in 2 countries.
Trial summary
This multi-center, randomized controlled feasibility trial will assess a 20-week home-based exercise intervention in youth with Multiple Sclerosis (MS). The goal is to determine the feasibility of conducting a larger, definitive trial on exercise training as a non-pharmacological approach to improve disease outcomes… Read more about this study
- Who is it for?
- Ages 11 to 25 years
- Conditions the study is for
- Neuroinflammatory Diseases, Multiple Sclerosis
- What is being tested?
- Exercise Training and Mobility and Flexibility Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jun 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Youth and young adults 11-25 years of age
- MS diagnosis or clinically isolated syndrome per revised McDonald diagnostic criteria and International Pediatric MS Study Group Criteria
- A score of 10 or above on the CES-DC scale.
Who cannot join
- Have non-specific white matter abnormalities and metabolic or infectious etiologies for white matter abnormalities
- Do not speak and read English at a level needed to complete the questionnaires (4th grade level)
- Have significant motor disability (EDSS ≥4)
- Are at increased risk of cardiac or other complications of exercise testing, as determined by the pediatric neurologist or physician
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
University of California, San Diego
La Jolla, California, 92093
Jennifer Graves, MD, 858-246-2384, jgraves@health.ucsd.edu
Sophie Zacharek, szacharek@health.ucsd.edu
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Gerry Liu, liug@chop.edu
Sona Narula, MD
Canada2 sites
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
Colin Wilbur, MD, colin.wilbur@albertahealthservices.ca
Colin Wilbur, MD
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Ann Yeh, MD, 416-813-7353, ann.yeh@sickkids.ca
Jesse Joynt, MSc, 416-813-7654 X415125, jesse.joynt@sickkids.ca
About this study
Official title: An Exercise Training Intervention for Depressive Symptoms in Youth With MS: A Randomized Controlled Feasibility Trial
This multi-center, randomized controlled feasibility trial will assess a 20-week home-based exercise intervention in youth with Multiple Sclerosis (MS). The goal is to determine the feasibility of conducting a larger, definitive trial on exercise training as a non-pharmacological approach to improve disease outcomes in this population.
Participants will be randomized to either an Exercise Training group or a Mobility and Flexibility Training group. The investigators will evaluate differences between the two groups in physical activity levels, mediators of physical activity, and psychosocial outcomes. Assessments, including clinical exams, brain MRI, eye tracking, cognitive testing, blood draws, and questionnaires, will occur at baseline and after 20 weeks. Accelerometry will be done at baseline, 10 weeks, and 20 weeks to track physical activity.
Read more
The primary objectives are to assess the feasibility of recruiting, retaining, and randomizing youth with MS and to evaluate adherence to the exercise intervention and coaching sessions. Exploratory objectives include examining changes in depressive symptoms, cognitive function, blood biomarkers (BDNF and irisin), brain volume, and fitness levels in response to the intervention.
Approximately 40 participants will be enrolled from four sites in Canada and the United States.
Primary outcomes include feasibility, acceptability, and fidelity measures. Exploratory outcomes include blood biomarkers, brain MRI, cognitive testing, and other neuropsychological measures.
Read the detailed description
Overview: This research study explores the potential of exercise as a non-pharmacological treatment for youth with Multiple Sclerosis (MS). The investigators are conducting a 20-week home-based exercise program to determine if it is feasible to implement this type of intervention in a larger trial in the future. Our ultimate goal is to understand how exercise might help improve both physical and mental health outcomes for youth with MS.
Why This Study is Important: Multiple Sclerosis is a chronic disease that affects the brain and spinal cord, often leading to issues with movement, balance, vision, and other body functions. In young people, MS can have a significant impact on daily life, including mental health and cognitive abilities (such as memory and problem-solving). Medications can help manage symptoms, but there is growing interest in non-medication approaches, like exercise, to enhance the overall well-being of youth with MS. This study aims to investigate whether a structured exercise program can benefit physical fitness, mental health, and brain function in young people living with MS.
Study Design: This feasibility trial will enroll approximately 40 participants from four different locations in Canada and the United States. These participants will be youth diagnosed with MS.
Participants will be randomly assigned to one of two groups:
- Exercise Training Group: Participants will follow a 20-week home-based exercise program, which includes structured exercises designed to improve physical fitness.
- Mobility and Flexibility Training: Participants in this group will follow a 20-week program focused on mobility and flexibility exercises.
The study will collect data through various assessments, including:
- Clinical Exams: To monitor physical health and MS-related symptoms.
- Brain MRI: To measure changes in brain structure.
- Eye Tracking (SickKids participants only): To assess brain activity and cognitive functions.
- Cognitive Testing: To evaluate memory, attention, and other cognitive abilities.
- Blood Draws: To measure blood biomarkers related to brain health, such as Brain-Derived Neurotrophic Factor (BDNF) and irisin, which are proteins thought to be linked to exercise benefits.
- Questionnaires: To gather information on mental health, including levels of depression and overall well-being.
- Accelerometry: To measure physical activity levels throughout the study.
What the Investigators Hope to Learn: The main goal of this study is to see whether it is practical to run a large-scale trial using a home-based exercise program for youth with MS. The investigators will look at whether it is possible to successfully recruit, retain, and engage participants in the program and how well they adhere to the exercise plan.
In addition to feasibility, the study has several exploratory objectives:
- Mental Health: The investigators want to see if participants in the exercise group show improvements in depressive symptoms compared to the control group.
- Cognition: The investigators will evaluate whether exercise has a positive effect on thinking skills, such as memory and attention.
- Brain Health: Through brain MRI scans, the investigators will examine whether exercise protects or enhances brain volume in areas linked to MS.
- Fitness Levels: The investigators will measure if participants improve their physical fitness as a result of the exercise program.
- Biomarkers: The investigators will study how exercise impacts blood levels of BDNF and irisin, which may provide insight into the biological mechanisms behind the benefits of exercise.
Why It Matters: This study is a critical first step in determining if exercise can be a viable and effective way to improve the lives of youth with MS. If successful, the findings will pave the way for a larger trial that could lead to new, non-medication-based treatments to improve mental health, cognitive function, and overall well-being in young people with MS.
By addressing the gaps in understanding how exercise benefits youth with MS, this research could offer valuable insights into developing better care strategies for this population. The results will inform not only how future exercise programs are designed but also provide a deeper understanding of the biological mechanisms linking physical activity to brain health and mood in youth with MS.
Study Locations: The study will take place across four sites:
- SickKids (Toronto, Canada)
- Stollery Children's Hospital (Edmonton, Canada)
- Children's Hospital of Philadelphia (Philadelphia, USA)
- University of California, San Diego (San Diego, USA)
How This Study Will Help in the Future: The information the investigators gather from this feasibility trial will help shape a larger, more definitive study to further explore whether exercise can be widely implemented as a safe and effective treatment option for youth with MS. It could lead to new therapeutic strategies that do not rely solely on medication but focus on holistic approaches to health and wellness.
- Conditions
- Neuroinflammatory Diseases, Multiple Sclerosis
- Being tested
- Exercise Training, Mobility and Flexibility Training
- Keywords
- multiple sclerosis, physical activity, depression, exercise intervention, biomarkers, irisin, brain-derived neurotrophic factor BDNF, randomized controlled trial, feasibility study, home-based exercise, youth, children, pediatric, brain and mental health
- Medical subject headings
- Neuroinflammatory Diseases, Multiple Sclerosis, Motor Activity, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingBehavioural
Also called Exercise Program for Youth with MS
The Exercise Training will follow a progressive interval-based training program designed for youth with MS. Participants will engage in three weekly exercise sessions. Participants will be given access to links to live virtual structured exercise sessions. The sessions will be scheduled weekly in partnership with a coach. A trained fitness instructor will lead the participants in a 10-minute warm-up, followed by 30 minutes of interval training, and a 10-minute stretching and cool down activity. Intervals will progress in intensity over the course of the 20-week program and progression will be based on individualized target heart rate zones. The session will be delivered via a live feed in order to foster social support from the participants peers enrolled in the program. Participants will have the option of completing the class in real-time and make up classes will also be available through a repository of sessions accessible through links to the repository cloud.
Mobility and Flexibility TrainingBehavioural
Also called Mobility and Flexibility Training Program
The Mobility and Flexibility Training will be focused on improving mobility and flexibility through three times a week stretching and mobility program. A 5-minute warm up will be followed by a series of stretches and mobility patterns that will be repeated as a circuit four times. Each session will focus on a specific muscle group - upper body, lower body or core. The classes will be led by a fitness instructor in the same manner as the exercise intervention arm with a virtual link sent to the participants.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training Group | Active comparator | The exercise training will follow a progressive interval-based training program designed for youth with MS. Participants will engage in three weekly exercise sessions. Participants will be given access to links to live virtual structured exercise sessions. The sessions will be scheduled weekly in partnership with a coach. A trained fitness instructor will lead the participants in a 10-minute warm-up, followed by 30 minutes of interval training, and a 10-minute stretching and cool down activity. Intervals will progress in intensity over the course of the 20-week program and progression will be based on individualized target heart rate zones established from baseline exercise testing. Receives: Behavioral: Exercise Training |
| Mobility & Flexibility Training Group | Sham comparator | The Mobility \& Flexibility Training Program focuses on mobility and flexibility. The training will be focused on improving mobility and flexibility through three times a week stretching and mobility program. A 5-minute warm up will be followed by a series of stretches and mobility patterns that will be repeated as a circuit four times. Each session will focus on a specific muscle group - upper body, lower body or core. The classes will be led by a fitness instructor in the same manner as the exercise group with a virtual link sent to the participants. Receives: Behavioral: Mobility and Flexibility Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant accrual rate
Number of participants enrolled per year
Measured: From enrollment to the end of study
Fidelity of delivering the intervention
ASPIRE fidelity coaching checklist. This measure assesses the fidelity with which study coaches deliver the intervention during calls with participants. Participants are scored on a scale from 0 to 2, based on the extent to which the intervention components are covered:
0: Did not cover - The intervention component was not addressed during the call.
- Partially covered - The intervention component was addressed to some extent, but not fully.
- Fully covered - The intervention component was fully addressed, meeting the intended criteria for delivery.
A higher score reflects a more complete and accurate delivery of the intervention as planned.
Measured: From enrollment to the end of intervention at 20 weeks
Participant drop-out rate
Percentage of total patients that dropped out of study.
Measured: From enrollment to the end of study
Adverse event rate
Number of adverse events per total participants
Measured: From enrollment to the end of study
Completion rate of study measures
Percentage of total patients that completed the study measures.
Measured: From enrollment to the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study startJun 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Neuroinflammatory DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized at the time of enrolment to either an Exercise Training group or a Mobility and Flexibility Training group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society, Multiple Sclerosis Society of Canada, University of California, San Diego, Children's Hospital of Philadelphia, Alberta Health Services, Calgary, Queen's University, University of Illinois at Chicago, Unity Health Toronto
- Responsible party
- Principal investigator, E. Ann Yeh, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870968
- Sponsor's protocol ID
- 1000080992
- Acronym
- FIT-ATOMIC
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.
PubMed 29275977Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.
PubMed 21387374Krupp LB, Banwell B, Tenembaum S; International Pediatric MS Study Group. Consensus definitions proposed for pediatric multiple sclerosis and related disorders. Neurology. 2007 Apr 17;68(16 Suppl 2):S7-12. doi: 10.1212/01.wnl.0000259422.44235.a8.
PubMed 17438241Stephens S, Schneiderman JE, Finlayson M, Berenbaum T, Motl RW, Yeh EA. Feasibility of a theory-informed mobile app for changing physical activity in youth with multiple sclerosis. Mult Scler Relat Disord. 2022 Feb;58:103467. doi: 10.1016/j.msard.2021.103467. Epub 2021 Dec 20.
PubMed 34954651Motl RW, Backus D, Neal WN, Cutter G, Palmer L, McBurney R, Schmidt H, Bethoux F, Hebert J, Ng A, McCully KK, Plummer P. Rationale and design of the STEP for MS Trial: Comparative effectiveness of Supervised versus Telerehabilitation Exercise Programs for Multiple Sclerosis. Contemp Clin Trials. 2019 Jun;81:110-122. doi: 10.1016/j.cct.2019.04.013. Epub 2019 Apr 22.
PubMed 31022481Stephens S, Berenbaum T, Finlayson M, Motl RW, Yeh EA. Youth with multiple sclerosis have low levels of fitness. Mult Scler. 2021 Sep;27(10):1597-1605. doi: 10.1177/1352458520974360. Epub 2020 Nov 27.
PubMed 33245672Bilek F, Cetisli-Korkmaz N, Ercan Z, Deniz G, Demir CF. Aerobic exercise increases irisin serum levels and improves depression and fatigue in patients with relapsing remitting multiple sclerosis: A randomized controlled trial. Mult Scler Relat Disord. 2022 May;61:103742. doi: 10.1016/j.msard.2022.103742. Epub 2022 Mar 15.
PubMed 35349884Spalletta G, Piras F, Caltagirone C, Fagioli S. Hippocampal multimodal structural changes and subclinical depression in healthy individuals. J Affect Disord. 2014 Jan;152-154:105-12. doi: 10.1016/j.jad.2013.05.068. Epub 2013 Jun 22.
PubMed 23800444Nabkasorn C, Miyai N, Sootmongkol A, Junprasert S, Yamamoto H, Arita M, Miyashita K. Effects of physical exercise on depression, neuroendocrine stress hormones and physiological fitness in adolescent females with depressive symptoms. Eur J Public Health. 2006 Apr;16(2):179-84. doi: 10.1093/eurpub/cki159. Epub 2005 Aug 26.
PubMed 16126743Wrann CD, White JP, Salogiannnis J, Laznik-Bogoslavski D, Wu J, Ma D, Lin JD, Greenberg ME, Spiegelman BM. Exercise induces hippocampal BDNF through a PGC-1alpha/FNDC5 pathway. Cell Metab. 2013 Nov 5;18(5):649-59. doi: 10.1016/j.cmet.2013.09.008. Epub 2013 Oct 10.
PubMed 24120943Cotman CW, Berchtold NC, Christie LA. Exercise builds brain health: key roles of growth factor cascades and inflammation. Trends Neurosci. 2007 Sep;30(9):464-72. doi: 10.1016/j.tins.2007.06.011. Epub 2007 Aug 31.
PubMed 17765329Erickson KI, Voss MW, Prakash RS, Basak C, Szabo A, Chaddock L, Kim JS, Heo S, Alves H, White SM, Wojcicki TR, Mailey E, Vieira VJ, Martin SA, Pence BD, Woods JA, McAuley E, Kramer AF. Exercise training increases size of hippocampus and improves memory. Proc Natl Acad Sci U S A. 2011 Feb 15;108(7):3017-22. doi: 10.1073/pnas.1015950108. Epub 2011 Jan 31.
PubMed 21282661Parrish JB, Weinstock-Guttman B, Smerbeck A, Benedict RH, Yeh EA. Fatigue and depression in children with demyelinating disorders. J Child Neurol. 2013 Jun;28(6):713-8. doi: 10.1177/0883073812450750. Epub 2012 Jul 17.
PubMed 22805247Longoni G, Brown RA, Aubert-Broche B, Grover SA, Branson HM, Fetco D, Bar-Or A, Marrie RA, Motl RW, Collins DL, Narayanan S, Arnold DL, Banwell B, Yeh EA. Physical activity and dentate gyrus volume in pediatric acquired demyelinating syndromes. Neurol Neuroimmunol Neuroinflamm. 2018 Sep 6;5(6):e499. doi: 10.1212/NXI.0000000000000499. eCollection 2018 Nov.
PubMed 30211252Grover SA, Sawicki CP, Kinnett-Hopkins D, Finlayson M, Schneiderman JE, Banwell B, Till C, Motl RW, Yeh EA. Physical Activity and Its Correlates in Youth with Multiple Sclerosis. J Pediatr. 2016 Dec;179:197-203.e2. doi: 10.1016/j.jpeds.2016.08.104. Epub 2016 Oct 4.
PubMed 27717498
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exercise Training Intervention for Depressive Symptoms in Youth With MS: A Randomized Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT06870968
- Acronym / sponsor ID
- FIT-ATOMIC / 1000080992
- Conditions
- Neuroinflammatory Diseases, Multiple Sclerosis
- Keywords
- multiple sclerosis, physical activity, depression, exercise intervention, biomarkers, irisin, brain-derived neurotrophic factor BDNF, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society, Multiple Sclerosis Society of Canada, University of California, San Diego, Children's Hospital of Philadelphia, Alberta Health Services, Calgary, Queen's University, University of Illinois at Chicago, Unity Health Toronto
- Study start
- Jun 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-center, randomized controlled feasibility trial will assess a 20-week home-based exercise intervention in youth with Multiple Sclerosis (MS). The goal is to determine the feasibility of conducting a larger, definitive trial on exercise training as a non-pharmacological approach to improve disease outcomes in this population.
Participants will be randomized to either an Exercise Training group or a Mobility and Flexibility Training group. The investigators will evaluate differences between the two groups in physical activity levels, mediators of physical activity, and psychosocial outcomes. Assessments, including clinical exams, brain MRI, eye tracking, cognitive testing, blood draws, and questionnaires, will occur at baseline and after 20 weeks. Accelerometry will be done at baseline, 10 weeks, and 20 weeks to track physical activity.
The primary objectives are to assess the feasibility of recruiting, retaining, and randomizing youth with MS and to evaluate adherence to the exercise intervention and coaching sessions. Exploratory objectives include examining changes in depressive symptoms, cognitive function, blood biomarkers (BDNF and irisin), brain volume, and fitness levels in response to the intervention.
Approximately 40 participants will be enrolled from four sites in Canada and the United States.
Primary outcomes include feasibility, acceptability, and fidelity measures. Exploratory outcomes include blood biomarkers, brain MRI, cognitive testing, and other neuropsychological measures.
Detailed description
Overview: This research study explores the potential of exercise as a non-pharmacological treatment for youth with Multiple Sclerosis (MS). The investigators are conducting a 20-week home-based exercise program to determine if it is feasible to implement this type of intervention in a larger trial in the future. Our ultimate goal is to understand how exercise might help improve both physical and mental health outcomes for youth with MS.
Why This Study is Important: Multiple Sclerosis is a chronic disease that affects the brain and spinal cord, often leading to issues with movement, balance, vision, and other body functions. In young people, MS can have a significant impact on daily life, including mental health and cognitive abilities (such as memory and problem-solving). Medications can help manage symptoms, but there is growing interest in non-medication approaches, like exercise, to enhance the overall well-being of youth with MS. This study aims to investigate whether a structured exercise program can benefit physical fitness, mental health, and brain function in young people living with MS.
Study Design: This feasibility trial will enroll approximately 40 participants from four different locations in Canada and the United States. These participants will be youth diagnosed with MS.
Participants will be randomly assigned to one of two groups:
- Exercise Training Group: Participants will follow a 20-week home-based exercise program, which includes structured exercises designed to improve physical fitness.
- Mobility and Flexibility Training: Participants in this group will follow a 20-week program focused on mobility and flexibility exercises.
The study will collect data through various assessments, including:
- Clinical Exams: To monitor physical health and MS-related symptoms.
- Brain MRI: To measure changes in brain structure.
- Eye Tracking (SickKids participants only): To assess brain activity and cognitive functions.
- Cognitive Testing: To evaluate memory, attention, and other cognitive abilities.
- Blood Draws: To measure blood biomarkers related to brain health, such as Brain-Derived Neurotrophic Factor (BDNF) and irisin, which are proteins thought to be linked to exercise benefits.
- Questionnaires: To gather information on mental health, including levels of depression and overall well-being.
- Accelerometry: To measure physical activity levels throughout the study.
What the Investigators Hope to Learn: The main goal of this study is to see whether it is practical to run a large-scale trial using a home-based exercise program for youth with MS. The investigators will look at whether it is possible to successfully recruit, retain, and engage participants in the program and how well they adhere to the exercise plan.
In addition to feasibility, the study has several exploratory objectives:
- Mental Health: The investigators want to see if participants in the exercise group show improvements in depressive symptoms compared to the control group.
- Cognition: The investigators will evaluate whether exercise has a positive effect on thinking skills, such as memory and attention.
- Brain Health: Through brain MRI scans, the investigators will examine whether exercise protects or enhances brain volume in areas linked to MS.
- Fitness Levels: The investigators will measure if participants improve their physical fitness as a result of the exercise program.
- Biomarkers: The investigators will study how exercise impacts blood levels of BDNF and irisin, which may provide insight into the biological mechanisms behind the benefits of exercise.
Why It Matters: This study is a critical first step in determining if exercise can be a viable and effective way to improve the lives of youth with MS. If successful, the findings will pave the way for a larger trial that could lead to new, non-medication-based treatments to improve mental health, cognitive function, and overall well-being in young people with MS.
By addressing the gaps in understanding how exercise benefits youth with MS, this research could offer valuable insights into developing better care strategies for this population. The results will inform not only how future exercise programs are designed but also provide a deeper understanding of the biological mechanisms linking physical activity to brain health and mood in youth with MS.
Study Locations: The study will take place across four sites:
- SickKids (Toronto, Canada)
- Stollery Children's Hospital (Edmonton, Canada)
- Children's Hospital of Philadelphia (Philadelphia, USA)
- University of California, San Diego (San Diego, USA)
How This Study Will Help in the Future: The information the investigators gather from this feasibility trial will help shape a larger, more definitive study to further explore whether exercise can be widely implemented as a safe and effective treatment option for youth with MS. It could lead to new therapeutic strategies that do not rely solely on medication but focus on holistic approaches to health and wellness.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized at the time of enrolment to either an Exercise Training group or a Mobility and Flexibility Training group.
| Arm | Type | Receives |
|---|---|---|
| Exercise Training Group | Active comparator | Behavioral: Exercise TrainingThe exercise training will follow a progressive interval-based training program designed for youth with MS. Participants will engage in three weekly exercise sessions. Participants will be given access to links to live virtual structured exercise sessions. The sessions will be scheduled weekly in partnership with a coach. A trained fitness instructor will lead the participants in a 10-minute warm-up, followed by 30 minutes of interval training, and a 10-minute stretching and cool down activity. Intervals will progress in intensity over the course of the 20-week program and progression will be based on individualized target heart rate zones established from baseline exercise testing. |
| Mobility & Flexibility Training Group | Sham comparator | Behavioral: Mobility and Flexibility TrainingThe Mobility \& Flexibility Training Program focuses on mobility and flexibility. The training will be focused on improving mobility and flexibility through three times a week stretching and mobility program. A 5-minute warm up will be followed by a series of stretches and mobility patterns that will be repeated as a circuit four times. Each session will focus on a specific muscle group - upper body, lower body or core. The classes will be led by a fitness instructor in the same manner as the exercise group with a virtual link sent to the participants. |
Who may qualify
- Ages
- 11 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Youth and young adults 11-25 years of age
- MS diagnosis or clinically isolated syndrome per revised McDonald diagnostic criteria and International Pediatric MS Study Group Criteria
- A score of 10 or above on the CES-DC scale.
Key exclusion criteria (4 listed)
- Have non-specific white matter abnormalities and metabolic or infectious etiologies for white matter abnormalities
- Do not speak and read English at a level needed to complete the questionnaires (4th grade level)
- Have significant motor disability (EDSS ≥4)
- Are at increased risk of cardiac or other complications of exercise testing, as determined by the pediatric neurologist or physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TrainingAlso: Exercise Program for Youth with MSThe Exercise Training will follow a progressive interval-based training program designed for youth with MS. Participants will engage in three weekly exercise sessions. Participants will be given access to links to live virtual structured exercise sessions. The sessions will be scheduled weekly in partnership with a coach. A trained fitness instructor will lead the participants in a 10-minute warm-up, followed by 30 minutes of interval training, and a 10-minute stretching and cool down activity. Intervals will progress in intensity over the course of the 20-week program and progression will be based on individualized target heart rate zones. The session will be delivered via a live feed in order to foster social support from the participants peers enrolled in the program. Participants will have the option of completing the class in real-time and make up classes will also be available through a repository of sessions accessible through links to the repository cloud. | Behavioural | Exercise Training Group |
| Mobility and Flexibility TrainingAlso: Mobility and Flexibility Training ProgramThe Mobility and Flexibility Training will be focused on improving mobility and flexibility through three times a week stretching and mobility program. A 5-minute warm up will be followed by a series of stretches and mobility patterns that will be repeated as a circuit four times. Each session will focus on a specific muscle group - upper body, lower body or core. The classes will be led by a fitness instructor in the same manner as the exercise intervention arm with a virtual link sent to the participants. | Behavioural | Mobility & Flexibility Training Group |
Primary outcome
Participant accrual rate
Time frame: From enrollment to the end of study
Number of participants enrolled per year
Fidelity of delivering the intervention
Time frame: From enrollment to the end of intervention at 20 weeks
ASPIRE fidelity coaching checklist. This measure assesses the fidelity with which study coaches deliver the intervention during calls with participants. Participants are scored on a scale from 0 to 2, based on the extent to which the intervention components are covered: 0: Did not cover - The intervention component was not addressed during the call. 1. Partially covered - The intervention component was addressed to some extent, but not fully. 2. Fully covered - The intervention component was fully addressed, meeting the intended criteria for delivery. A higher score reflects a more complete and accurate delivery of the intervention as planned.
Participant drop-out rate
Time frame: From enrollment to the end of study
Percentage of total patients that dropped out of study.
Adverse event rate
Time frame: From enrollment to the end of study
Number of adverse events per total participants
Completion rate of study measures
Time frame: From enrollment to the end of study
Percentage of total patients that completed the study measures.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Results publication: PubMed 29275977Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.
- Results publication: PubMed 21387374Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.
- Results publication: PubMed 17438241Krupp LB, Banwell B, Tenembaum S; International Pediatric MS Study Group. Consensus definitions proposed for pediatric multiple sclerosis and related disorders. Neurology. 2007 Apr 17;68(16 Suppl 2):S7-12. doi: 10.1212/01.wnl.0000259422.44235.a8.
- Results publication: PubMed 34954651Stephens S, Schneiderman JE, Finlayson M, Berenbaum T, Motl RW, Yeh EA. Feasibility of a theory-informed mobile app for changing physical activity in youth with multiple sclerosis. Mult Scler Relat Disord. 2022 Feb;58:103467. doi: 10.1016/j.msard.2021.103467. Epub 2021 Dec 20.
- Results publication: PubMed 31022481Motl RW, Backus D, Neal WN, Cutter G, Palmer L, McBurney R, Schmidt H, Bethoux F, Hebert J, Ng A, McCully KK, Plummer P. Rationale and design of the STEP for MS Trial: Comparative effectiveness of Supervised versus Telerehabilitation Exercise Programs for Multiple Sclerosis. Contemp Clin Trials. 2019 Jun;81:110-122. doi: 10.1016/j.cct.2019.04.013. Epub 2019 Apr 22.
- Results publication: PubMed 33245672Stephens S, Berenbaum T, Finlayson M, Motl RW, Yeh EA. Youth with multiple sclerosis have low levels of fitness. Mult Scler. 2021 Sep;27(10):1597-1605. doi: 10.1177/1352458520974360. Epub 2020 Nov 27.
- Results publication: PubMed 35349884Bilek F, Cetisli-Korkmaz N, Ercan Z, Deniz G, Demir CF. Aerobic exercise increases irisin serum levels and improves depression and fatigue in patients with relapsing remitting multiple sclerosis: A randomized controlled trial. Mult Scler Relat Disord. 2022 May;61:103742. doi: 10.1016/j.msard.2022.103742. Epub 2022 Mar 15.
- Results publication: PubMed 23800444Spalletta G, Piras F, Caltagirone C, Fagioli S. Hippocampal multimodal structural changes and subclinical depression in healthy individuals. J Affect Disord. 2014 Jan;152-154:105-12. doi: 10.1016/j.jad.2013.05.068. Epub 2013 Jun 22.
- Results publication: PubMed 16126743Nabkasorn C, Miyai N, Sootmongkol A, Junprasert S, Yamamoto H, Arita M, Miyashita K. Effects of physical exercise on depression, neuroendocrine stress hormones and physiological fitness in adolescent females with depressive symptoms. Eur J Public Health. 2006 Apr;16(2):179-84. doi: 10.1093/eurpub/cki159. Epub 2005 Aug 26.
- Results publication: PubMed 24120943Wrann CD, White JP, Salogiannnis J, Laznik-Bogoslavski D, Wu J, Ma D, Lin JD, Greenberg ME, Spiegelman BM. Exercise induces hippocampal BDNF through a PGC-1alpha/FNDC5 pathway. Cell Metab. 2013 Nov 5;18(5):649-59. doi: 10.1016/j.cmet.2013.09.008. Epub 2013 Oct 10.
- Results publication: PubMed 17765329Cotman CW, Berchtold NC, Christie LA. Exercise builds brain health: key roles of growth factor cascades and inflammation. Trends Neurosci. 2007 Sep;30(9):464-72. doi: 10.1016/j.tins.2007.06.011. Epub 2007 Aug 31.
- Results publication: PubMed 21282661Erickson KI, Voss MW, Prakash RS, Basak C, Szabo A, Chaddock L, Kim JS, Heo S, Alves H, White SM, Wojcicki TR, Mailey E, Vieira VJ, Martin SA, Pence BD, Woods JA, McAuley E, Kramer AF. Exercise training increases size of hippocampus and improves memory. Proc Natl Acad Sci U S A. 2011 Feb 15;108(7):3017-22. doi: 10.1073/pnas.1015950108. Epub 2011 Jan 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training and Mobility and Flexibility Training in people with Neuroinflammatory Diseases and Multiple Sclerosis, run by The Hospital for Sick Children at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ann Yeh, MD (416-813-7353, ann.yeh@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant accrual rate (time frame: From enrollment to the end of study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06870968, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.